Chelsea has reached its target enrollment of 82 patients for Study 302, the first of two pivotal phase-III clinical trials in Chelsea’s registration program of Droxidopa. It is intended for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
The Droxidopa phase-III registration program in NOH includes two highly similar, double-blind, placebo-controlled studies, Study 301 and Study 302. Both studies compare Droxidopa to placebo for the treatment of symptomatic NOH, and are designed to demonstrate a mean improvement over placebo of 1.6 units on the Orthostatic Hypotension Symptom Assessment scale.
Simon Pedder, President and CEO, Chelsea, said: We are delighted to have reached our target enrollment in Study 302 as this milestone moves us closer to our goal of initiating a US marketing application by year-end and bringing Droxidopa to market for patients suffering from neurogenic orthostatic hypotension.”
As the only therapeutic agent treating the underlying cause of neurogenic orthostatic hypotension, Droxidopa has the potential to become the first line treatment for a significant number of patients in this country. We sincerely appreciate the participation of all the clinicians and patients in this trial who share Chelsea’s commitment to address the needs of this underserved population. With them, we eagerly look forward to seeing the top-line results from this trial and completing enrollment in our second on-going Phase III trial in the third quarter, he added.